NIAGARA
The first immunotherapy shown to improve survival when given around bladder-removal surgery.
EFS HR 0.68 (median not reached vs 46.1 months); OS HR 0.75; pCR 37.3% vs 27.5%. FDA approval 28 March 2025, the first perioperative immunotherapy for MIBC. Establishes a new baseline that EV-304 now challenges.
Setting
Cisplatin-eligible muscle-invasive bladder cancer: neoadjuvant durvalumab + gemcitabine-cisplatin, cystectomy, adjuvant durvalumab vs neoadjuvant chemotherapy and cystectomy
Phase
Phase 3
Sponsor
AstraZeneca
Registry
Headline result
EFS HR 0.68; OS HR 0.75.
Reported
2024
Enrolled
1063
Replication
Perioperative IO benefit replicated in principle by EV-303 and EV-304 (with an ADC partner) and by adjuvant CheckMate 274.
In plain words
What these results mean for people, not percentages
Event-free survivalprimarysurrogate endpoint
- Median 46.1 months with Chemo + cystectomy.
- Durvalumab + chemo, perioperative: median not reached.
- "Not reached" means that, when the data were analysed, more than half of that group had not yet had the event, which is good news for that group.
- A median is a midpoint: half the people did better than this and half did worse.
- Put another way, the treated group had about 32 percent lower chance of the event at any given time (hazard ratio 0.68, likely range 0.56 to 0.82).
- This is a surrogate endpoint: it measures the cancer being controlled or absent on scans and tests, which often, but not always, translates into living longer.
Overall survivalsurvival endpoint
- The treated group had about 25 percent lower chance of the event at any given time (hazard ratio 0.75).
- The absolute difference, how many more people out of 100 were helped, is not reported here.
- not reached not reached
- Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
Be careful
- These results apply to the people the trial enrolled: Cisplatin-eligible muscle-invasive bladder cancer: neoadjuvant durvalumab + gemcitabine-cisplatin, cystectomy, adjuvant durvalumab vs neoadjuvant chemotherapy and cystectomy. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
1,063 participants enrolled.
Event-free survivalprimary
HR 0.68 (0.56–0.82) · p <0.001
Durvalumab + chemo, perioperative
median not reached
Chemo + cystectomy
46.1 mo
median not reached
SourceOverall survival
HR 0.75 (0.59–0.93) · p = 0.01
not reached · not reached
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Event-free survivalprimary | Durvalumab + chemo, perioperative | 533 | median not reached | 0.68 (0.56–0.82) | <0.001 | link |
| Chemo + cystectomy | 530 | 46.1 months | ||||
| Overall survival | Durvalumab arm | — | not reached | 0.75 (0.59–0.93) | 0.01 | — |
| Control | — | not reached |
Replication
Perioperative IO benefit replicated in principle by EV-303 and EV-304 (with an ADC partner) and by adjuvant CheckMate 274.